Tuesday, September 23, 2014

Dr Accuses GSK of Breaking Their Corporate Integrity Agreement

In July 2012 GlaxoSmithKline entered into a Corporate Integrity Agreement (CIA) that obligated them to collect and report on payments and transfers of value to US physicians and US healthcare organizations.

The Corporate Integrity Agreement signed by GSK with the Office of the Inspector General for the Department of Health and Human Services in June 2012 also requires the them to disclose payments and transfers of value to US physicians.

Two years on and what do we have?

A post published on metabolism.com on September 22, 2014 by Dr. S. Brown is accusing Glaxo of going back on their word, thus breaking the Corporate Integrity Agreement.

According to the author, GSK have released a list of 168 physician lecturers, specifically trained to promote their new diabetes product, Tanzeum.

Albiglutide, which is marketed as Tanzeum, was approved by the FDA earlier this year, can be used as a stand-alone therapy or in combination with other Type 2 diabetes therapies, including insulin and metformin. FDA says albiglutide shouldn't be used to treat people who have Type 1 diabetes.

Okay, so the pledge, according to a 2013 article in the New York Times, would be completed worldwide by 2016.

In the NYT article Glaxo chief Andrew Witty said...

“We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

The 2013 NYT article also states that "Glaxo will continue to pay doctors consulting fees for market research because Mr. Witty said it was necessary for the company to gain insight from doctors about their products, but he said that activity would be limited in scope."

Are we to assume that Glaxo are not actually breaking any agreement (yet) because they have penciled in a 2016 target?

It seems to be a half-assed way to achieve a target of compliance by GSK, or are we to assume that , as Brown suggests, "using doctors to promote their products was just too successful a tactic to give up"?

Brown's post, "Glaxo-SmithKline Reneges on Pledge to End Paid Physician Promoters" offers no evidence or the list of the 168 physician lecturers targeted by GSK.

If true, let's hope that those paid physicians and Glaxo will stick to the guidance of the FDA and not promote Tanzeum for other off-label uses.